Depression, Hepatitis C
Conditions
Keywords
Hepatitis C, Depression, Collaborative care, Antiviral treatment
Brief summary
Chronic infection with hepatitis C (CHC) is a common and expensive condition, and it disproportionately affects Veterans. Treatment with antiviral therapy reduces liver disease progression and improves health related quality of life. However, \ 70% of Veterans with CHC are considered ineligible for antiviral treatment. Most of these patients are excluded due to the presence of co-existing depression and substance use. The proposed project will adapt and adopt an evidence-based collaborative depression care model in CHC clinics. By removing the leading contraindication for antiviral treatment, this project will potentially yield benefits that go far beyond the obvious quality of life benefit from antidepressant therapy itself.
Detailed description
Project Background and Rationale: Depression is highly prevalent, yet under-diagnosed and under-treated in CHC. Treatment models that increase collaborative management of depression by mental health and physical health clinicians can improve quality and outcomes, and collaborative care models have been identified as the best-practice for depression in VA primary care settings. However, the antiviral treatment for CHC patients may not benefit from the existing primary care-mental health integration because the antiviral treatment is time-limited and conducted in specialty clinics. Although there is little evidence evaluating the effects of collaborative depression care in specialty settings, QUERI HIV-hepatitis initiated one of the first such efforts that effectively implemented collaborative depression care in HIV clinics. Built on this experience, an intensive yet focused collaborative care model in CHC clinics may be effective in improving not only depression but also CHC care. This proposed study, Hepatitis-Translating Initiatives for Depression into Effective Solutions (HEP-TIDES) will target this issue. Project Objectives: The proposal has three overarching primary aims and one exploratory aim. The primary aims are (1) adapt and adopt the collaborative care model for improving depression care in specialty CHC care settings, (2) compare the effectiveness of HEP-TIDES to usual care in improving CHC care, and (3) compare the effectiveness of HEP-TIDES to usual care in improving depression care. The exploratory aim is to evaluate the cost-effectiveness of HEP-TIDES versus usual care. Project Methods: HEP-TIDES is a multi-site, multi-method implementation project. HEP-TIDES will use evidence-based quality improvement (EBQI) methods to adapt and implement depression screening and the collaborative care model for depression in the CHC clinics at 4 disparate VA facilities (aim 1). HEP-TIDES will involve CHC and mental health providers working with an off-site depression care team comprised of a depression care nurse manager, pharmacist, and a psychiatrist. The purpose of the team will be to support CHC and mental health clinicians in delivering evidence-based stepped-care depression treatment. The adapted model will also take into account the substance use disorders among CHC patients. HEP-TIDES implementation will be assessed using a formative evaluation of the implementation process and a summative evaluation of a randomized controlled implementation trial of collaborative depression care in 242 patients (aims 2 and 3).
Interventions
OTHERDepression collaborative care model
The intervention will include a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* confirmed untreated infection (positive HCV RNA test) * current PHQ-9 score of 10 or more * current treatment in the CHC clinic
Exclusion criteria
* non-Veterans * patients who do not have access to a telephone * patients with current suicidal ideation * patients with significant cognitive impairment as indicated by a score \> 10 on the Blessed Orientation Memory and Concentration Test * patients with a chart diagnosis of schizophrenia * patients with a chart diagnosis of bipolar disorder who have been hospitalized for a mental health condition within the last 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment | 12 months | Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise. |
| Depression Care: Treatment Response | Baseline and 12 months | Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline. |
| Depression Care: Depression Remission | Baseline and 12 months | Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5. |
| Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months | From Baseline to 12 months | The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received | 12 months | Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe. |
| Medication Adherence: Medication Possession Ratio | 12 months | Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day's supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement. |
Countries
United States
Participant flow
Recruitment details
We recruited a total of 309 patients from CHC clinics at 4 VAs (Houston, St Louis, Little Rock, and Los Angeles) between April 2012 and September 2013. Of these, 292 patients completed baseline interviews. Follow-up data-collection interviews were completed for 263 (90.1%) participants at 6-months and 242 (78.3%) participants at 12-months.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Depression Collaborative Care Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs. | 145 |
| Arm 2: Usual Care Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition. | 147 |
| Total | 292 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 6 | 3 |
| Overall Study | Did not complete Baseline Interview | 5 | 4 |
| Overall Study | Lost to Follow-up | 18 | 13 |
| Overall Study | Withdrawal by Subject | 13 | 5 |
Baseline characteristics
| Characteristic | Arm 1: Depression Collaborative Care | Total | Arm 2: Usual Care |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 5.8 | 59 years STANDARD_DEVIATION 5.5 | 59 years STANDARD_DEVIATION 5.2 |
| Annual Income Don't Know/Refused | 42 participants | 91 participants | 49 participants |
| Annual Income Less than $20,000 | 60 participants | 117 participants | 57 participants |
| Annual Income Over $20,000 | 43 participants | 84 participants | 41 participants |
| History of Mood Disorders Don't Know/Refused | 0 participants | 2 participants | 2 participants |
| History of Mood Disorders No | 80 participants | 158 participants | 78 participants |
| History of Mood Disorders Yes | 65 participants | 132 participants | 67 participants |
| Marital Status Married | 14 participants | 30 participants | 16 participants |
| Marital Status Other (divorced, widowed, separated, no response) | 86 participants | 149 participants | 63 participants |
| Marital Status Single, Never Married | 45 participants | 113 participants | 68 participants |
| Race/Ethnicity, Customized Black or African American | 72 participants | 163 participants | 91 participants |
| Race/Ethnicity, Customized Other | 14 participants | 29 participants | 15 participants |
| Race/Ethnicity, Customized White Non-Hispanic | 59 participants | 100 participants | 41 participants |
| Region of Enrollment United States | 145 participants | 292 participants | 147 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 139 Participants | 280 Participants | 141 Participants |
| Taking antidepressant meds at baseline Don't Know/Refused | 3 participants | 4 participants | 1 participants |
| Taking antidepressant meds at baseline No | 71 participants | 150 participants | 79 participants |
| Taking antidepressant meds at baseline Yes | 71 participants | 138 participants | 67 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 145 | 0 / 147 |
| serious Total, serious adverse events | 6 / 145 | 3 / 147 |
Outcome results
Primary
Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months
The change in Depression Free Days was assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression-free days (DFDs) were calculated using an SCL-20 score of less than 0.5 for depression-free and 2.0 or higher for fully symptomatic, and scores in between were assigned a linear proportional value.
Time frame: From Baseline to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Depression Collaborative Care | Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months | 118.74 Depression Free Days (DFDs) | Standard Deviation 106.68 |
| Arm 2: Usual Care | Depression Care: Change From Baseline in Number of Depression Free Days (DFDs) at 12 Months | 109.30 Depression Free Days (DFDs) | Standard Deviation 117.88 |
Primary
Depression Care: Depression Remission
Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Remission was defined as an item mean SCL-20 score of less than 0.5.
Time frame: Baseline and 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Depression Collaborative Care | Depression Care: Depression Remission | 22 participants |
| Arm 2: Usual Care | Depression Care: Depression Remission | 9 participants |
Primary
Depression Care: Treatment Response
Depression outcomes were assessed using the item mean score from the 20-item Hopkins Symptom Checklist (SCL-20) collected at baseline and 12-months. The SLC-20 items are scored from 0 to 4 and averaged to provide a mean depression severity score ranging from 0 to 4. Depression treatment response was defined as a 50% or greater decrease in the mean SCL-20 score compared with baseline.
Time frame: Baseline and 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Depression Collaborative Care | Depression Care: Treatment Response | 36 participants |
| Arm 2: Usual Care | Depression Care: Treatment Response | 19 participants |
Primary
Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment
Antiviral treatment initiation was measured dichotomously by assigning a value of 1 if the patient received at least one prescription of interferon within 12 months of enrollment, and a value of 0 otherwise.
Time frame: 12 months
Population: intent to treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Depression Collaborative Care | Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment | 11 participants |
| Arm 2: Usual Care | Number of Patients Who Initiated Hepatitis C Antiviral Treatment Within 12 Months of Enrollment | 7 participants |
Secondary
Medication Adherence: Medication Possession Ratio
Medication adherence was measured using the Medication Possession Ratio (MPR) calculation: Pharmacy refill data was used to calculate a medication possession ratio (MPR), by dividing the number of days supply of a medication received by the number of day's supply the patient needed to be able to take the medication continuously. An MPR closer to 1.0 indicates better adherence and has been associated with lower rates of hospital admission in veterans and greater symptom improvement.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Depression Collaborative Care | Medication Adherence: Medication Possession Ratio | .83 medication posession ratio | Standard Deviation 0.2 |
| Arm 2: Usual Care | Medication Adherence: Medication Possession Ratio | .78 medication posession ratio | Standard Deviation 0.24 |
Secondary
Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received
Quality of CHC Indicator Measure is based on a Delphi panel-derived list of quality indicators (QI) in CHC care. The list spans the following domains of care, i.e., CHC-specific function of care (diagnosis, specialty evaluation, treatment, etc); general function of care (diagnosis, treatment, follow-up); and mode of care (encounter, medication, immunization, counseling, etc). Adherence to a given QI is scored as 1 if there is evidence in the patient EMR for the indicator being satisfied. The quality of CHC care at the patient level is calculated by dividing the number of QIs for which that individual received the indicated care by the number of QIs for which the individual is eligible for during the length of time the patient is enrolled in the HEP-TIDES 12-month study timeframe.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1: Depression Collaborative Care | Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received | .89 proportion of QIs met | Standard Deviation 0.16 |
| Arm 2: Usual Care | Quality of Hepatitis C Care: Quality Indicators: Proportion of QIs Received | .83 proportion of QIs met | Standard Deviation 0.19 |